This invention relates to the problem of male impotence and is a method of temporarily alleviating and treating impotence by aiding in producing, enhancing, and sustaining an erection of the penis.
The ability to attain and maintain an adequate erection has long been a problem to older men as well as to some younger men experiencing psychogenic or physiologic impotence due to various factors. This invention is the first really viable solution to this problem, and is a solution involving no tourniquets, straps, bands, sleeves, or other supportive devices used in the past to aid in effecting an erection. There have been numerous attempts to treat impotence by the administration of certain drugs, but none thus far has been really successful in aiding the impotent.
Whether the impotence is absolute (involving all sexual modalities), total (also affecting all sexual functions, though not necessarily libido), or partial (affecting the rigidity or duration of erection), or whether the cause of impotence is organic (due to structural changes, disease, or some demonstrable functional impairment anywhere in the sexual system), psychogenic (due to psychological factors such as depression or aversion to a particular sex partner), or physiologic (due to old age or sexual satiation), the result is the same: inability to engage in sexual activity due (at least partially) to the lack of an adequate erection. Impotence may be defined more fully, however, as the inability to develop or sustain an erection of the penis sufficient to conclude coitus or orgasm and ejaculation to the male's own satisfaction. Impotence treatment methods are generally, however, concerned with the erection aspect and not ejaculatory impotence, which is relatively rare.
The penis becomes erect when certain tissues (e.g., the corpora cavernosa, 38 in FIG. 5) in the central portion of the penis become widely dilated with blood, thereby causing them to become less flaccid, and in turn causing an erection.
While the vast majority of impotence treatment methods have been concerned with exogenous nervous stimulation of the organ to produce an erection by, for example, local stimulation via vibration, many blood constrictive devices have been proposed throughout this century for producing and enhancing an erection. Typically, these are adjustable, tourniquet-like rubber band devices which are designed to fit tightly around the shaft of the penis and thereby restrict the flow of blood from the penis through the surface veins, as well as the deeper dorsal vein, to prolong an erection. For example, Atchley U.S. Pat. No. 3,636,948 discloses an adjustable device designed to fit the contour of the penis, to exert greater pressure on the area where the subcutaneous (surface) veins are located, thereby restricting the blood exiting the penis through the peripheral veins. Similarly, Miller U.S. Pat. No. 2,818,855 is ineffective for depressing the deep dorsal vein and preventing or significantly restricting flow of blood there. There have been numerous other attempts to solve the problem, but all exhibit various disadvantages to the user, and sometimes to the female sex partner, such as extreme discomfort during intercourse, to the extent that users might not achieve the desired usefulness as frequently as desired and to the extent preferred. All the external devices previously proposed have the psychological disadvantage of being an impediment to the sex act, and the operational disadvantage that their duration of effectiveness is relatively short.
Impotence associated with androgen deficiency has long been thought by certain medical factions to be treatable by the administration of sex hormones via synthetic preparations such as methyl testosterone and various esters, including propionate, deconate, and enanthate, as well as a number of testosterone-aphrodisiac combinations. Androgen levels in the blood are known to decrease gradually with age, but the extent to which reduced hormone output seriously interferes with the sexual function is not really known, and there is some controversy as to whether the level of testosterone in blood plasma of impotent men is a significant indicator of its value in treatment. The prevailing view is that there is a definite correlation between testosterone levels and impotence. But see Racey, et al., Testosterone in Impotent Men, 59 Journal of Endocrinology xxiii (Nov. 1973), wherein it is reported that the concentration of testosterone in blood plasma of impotent patients did not differ significantly from that of a laboratory control group.
In some cases, however, steroid replacement therapy (periodic administration of androgens) has been found to reactivate lagging sexual response. Testosterone deficiency can cause sudden marked reduction in ejaculatory pressure and seminal fluid output, and repeated prostatic pain from sustained contraction of the organ during intercourse. Accordingly, extended experimental studies of testosterone therapy have been conducted, some with good results.
Mesterolone is a synthesized androgen which is distinguished from most other orally effective steroids by the lack of a 17-alkyl group. The compound has an androgenic effect equal to that of methyl testosterone, but is superior in effect in that it has virtually no toxicity to humans if administered within conventional therapeutic dose ranges. Also, unlike methyl testosterone, it has not been found to inhibit endogenous testosterone formation or spermatogenesis. Mesterolone has, however, been found to be a poor means of treating impotence. See Cooper and Ismail, A Pilot Study of Mesterolone and Impotence, 26 Psychopharmacologia 379, 380 (1972). The lack of response to mesterolone indicates that testosterone levels per se may be irrelevant to adult potency, and thus lends credence to the proposition that the administration of testosterone and other synthesized androgens are not only ineffective in the long run, but possibly harmful as well.
Despite claims by some doctors such as Cooper and Ismail, of therapeutic success from testosterone treatments, the administration of exogenous hormones has several pharmacologic disadvantages. For example, methyl testosterone must be taken subcutaneously or bucally and is felt by some researchers to cause severe toxic effects such as cholestatic jaundice. Parenterally administered testosterone esters, while less toxic and more certainly absorbed than methyl testosterone, have all the drawbacks of intramuscular administration; not only is there more pain, but the deeply injected medication frequently isn't absorbed adequately, and the risk of deeper and more widespread infection is more serious. Also, long-term administration of these synthetic compounds may inhibit endogenous testosterone formation and spermatogenesis by supressing pituitary gonadotrophins, thereby resulting in glandular tisuse atrophy because of disuse.
The risk of atrophy is heightened by certain studies which indicate that when testosterone is administered for the treatment of impotence associated with androgen deficiency, an adequate clinical response may require the maintenance of serum testosterone concentrations at a higher-than-normal level, higher than the conventional therapeutic dosage of 500 milligrams intramuscularly per week. See Sternberg, Testosterone in High Dosage for the Treatment of Impotence: Effect on Serum FSH When Combined With Chorionic Gonadotropin, 21 Journal of the American Geriatrics Society 271, 272 (1973). More conclusive studies involving treatment with testosterone are needed, as some researchers are extremely concerned that, in addition to testosterone's problems of ineffectiveness and gland atrophy, its use enhances existing cancers of the prostate gland.
Because of the uncertainty and the problems involved in the administration of testosterone in the treatment of impotence, there have been numerous non-androgen related attempts to treat the impotence problem, including treatments with yohimbine (an alkaloid from the bark of the yohimbihi tree), damiana, ginseng, levodopa (L-dihydrophenylalanine, metabolic precursor of the brain neurotransmitter amines -- dopamine and norepinephrine), hydergine (a combination of three hydrogenated ergot alkaloids -- adrenergic blocking agents), clomiphene (formerly used only as an ovulatory stimulant), phosphorous, strychnine, and cantharides (Spanish Fly). These are generally administered orally with varying degrees of success, some with significant side effects.
One androgen compound is a drug comprised of equal amounts of nux vomica extract, methyl testosterone, and yohimbine, marketed by Bentex Pharmaceutical Company of Houston under the mark Afrodex, found in clinical studies to provide a significant treatment effect in the treatment of male impotence. See Roberts and Sloboda, Afrodex vs. Plecebo in the Treatment of Male Impotence: Statistical Analysis of Two Double-Blind Crossover Studies, 16 Current Therapeutic Research 96 (1974). Afrodex, previously prescribed in 15 milligram oral dosages, three times a day, is no longer available on the market because its effectiveness was questionable.
Another non-steroid drug which has been found to have a significant effect in raising the level of urinary steroid matabolites, including testosterone in both normal and corticosteriod deficient males, is clomiphene, a non-steroid triethylene derivative. Only limited pilot studies have been conducted to determine its value as a possible alternative drug treatment in impotence. See Cooper, et al, The Effects of Clomiphene in Impotence: A clinical and Endocrine Study, 120 British Journal of Psychiatry 327 (1972).
The various problems involved in androgen treatments make it apparent that non-steroid treatment of impotence is the logical answer. The problem is to find a drug that will work in treating impotence, and to devise a means of administration that is both effective and harmless over a long period of time. Because of the unreliability and potential side effects involved in the oral administration of certain drugs that may be useful in treating impotence, the answer is a way to treat the impotence directly by effecting an erection. This is best done by administration into the penis itself, because the dosage may then be minimized since virtually all the dose acts directly on the penile tissues.
The subject invention provides a way to produce and enhance and even maintain an erection without the attendant difficulties inherent in oral administration of drugs or in use of a device or appliance that must be worn during intercourse. Various creams and rubbing compounds are available for external treatment of the skin surface of the penis, but nothing for treating the tissues which actually provide the erection. The invention, involving nothing which may be annoying or even apparent to the female sex partner, provides such a way by means of the injection of certain drugs into the corpora cavernosa of the penis with a hypodermic syringe.
Preferably, a dual needle syringe is used to inject both corpora cavernosa at the same time, because it's desirable to make injections simultaneously in cases where multiple injections are to be made relatively close together, as the patient will experience only one sensation of pain if the distance between the two needles does not exceed the distance at which the surface pain sensors of the skin can distinguish between single and multiple locations of pain. The two-point sensation of pain distance varies over different parts of the body.
The basic concept of the dual needle syringe is old, and numerous patents have been granted on various devices, for example Horn U.S. Pat. No. 3,552,394, which discloses a dual hypodermic syringe with integrally molded barrels and independent plungers and needles, apparently of the conventional variety. Accordingly, the subject invention provides a new way to produce an erection by simultaneously injecting an appropriate drug into the corpora cavernosa of the penis with a novel syringe designed expressly for this purpose.